MAUDE Adverse Event Report: SORIN GROUP USA, INC. VASCULEAR PRECISION BIPOLAR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number VC15

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2015

Event Type  Other  

Event Description

Sorin group received a report that during a vein harvesting procedure, the bipolar jaw broke off.The piece was retrieved form the patient's leg and discarded.The bipolar device was replaced and the procedure continued without any issues.There was no injury to the patient.

Manufacturer Narrative

Patient information was not provided.Sorin group received a report that during a vein harvesting procedure, the bipolar jaw broke off.The piece was retrieved from the patient's leg and discarded.The bipolar device was replaced and the procedure continued without any issues.There was no injury to the patient.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that during a vein harvesting procedure, the bipolar jaw broke off.The piece was retrieved from the patient's leg and discarded.The bipolar device was replaced and the procedure continued without any issues.There was no injury to the patient.One vascuclear precision bipolar device was returned to sorin group usa for further investigation.The device was subjected to visual inspection and functional testing.The visual inspection confirmed the user report that the upper jaw had broken off.The lower jaw was found to be undamaged.During testing, all functionalities of the device worked as expected.Based on the results of the evaluation of the returned device, it has been concluded that the issue was likely the result of advancing the bipolar with the jaws in the open position, contrary to the ifu.The vascuclear precision bipolar instructions for use states: "caution: do not advance or torque the instrument with the jaws open or use the jaws for spread dissection.These actions will damage the instrument.".

• Brand Name: VASCULEAR PRECISION BIPOLAR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4779005
• MDR Text Key: 5780199
• Report Number: 1718850-2015-00145
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: VC15
• Device Lot Number: 1504100111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1